How an East Bay city stepped up to boost a company's attack on Covid19

03May

BioGenex worked with Fremont city officials to ensure the supply of raw materials that were key to Roche's Covid-19 diagnostic.

The call came on a Monday in mid-March: A Covid-19 test by BioGenex Laboratories' big customer, Roche Molecular Solutions, had secured regulatory clearance, and the Fremont company would need to produce the critical raw material needed to make diagnostic kits to detect the coronavirus.

BioGenex worked with Fremont city officials to ensure the supply of raw materials that were key to Roche's Covid-19 diagnostic.

That meant more hazardous materials at BioGenex's Fremont facility than the company's permits would typically allow, so BioGenex co-founder and CEO Krishan Kalra called Tina Kapoor, Fremont's economic development manager. That normally would start an extended permitting process of meetings, public notices and hearings that could take two to four months.

The Food and Drug Administration's emergency use authorization of Roche's test was the first granted for unmasking the Covid-19 coronavirus, promising hundreds of thousands of tests as the virus continued to spread. But while Roche and BioGenex focused on the accuracy of the the test, Fremont city officials knew they had a role to play against the global pandemic, too: move safely but quickly.

Within eight days of Kalra's initial call to city officials — and after a number of morning, evening and weekend meetings — BioGenex had its permits.

"They became part of our team," Kalra said. "They helped us get through the process quickly."

Amid the Covid-19 crisis, Bay Area governments, such as Fremont, have cleared the regulatory decks as drug, device and diagnostic companies respond to the public health emergency. That doesn't mean relaxing regulations, said Briggs, but instead moving quickly through red tape so companies can get down to real-time life-saving work.

"BioGenex is the only one needing a specific approval, but others may have needed a minor inspection or other kind of service," Briggs said. "We have had over a dozen companies reach out to let us know that they are contributing to working on something deemed 'essential.'"

In BioGenex's case, Fremont pulled together its planning, economic development and fire department hazardous materials teams to check the quantities of the chemicals the company needed against its containment equipment, protective gear and emergency response policies.

Meanwhile, the company gathered paperwork, answered questions and shifted employees from slower parts of its business to the coronavirus team. It has not had to lay off or furlough any of its 100 employees, who normally produce chemicals used in other Roche tests for cancer, HIV and other diseases.

"We use chemicals all the time, but we needed to convince the city that we won't hurt our people or the neighbors or have a fire hazard," Kalpar said.

The scramble to boost production for Roche comes against the backdrop of promises and disappointments in the testing space. Testing procedures, personnel to collect sample and the capacity of the bulky machines that process the samples — along with political confusion — have delayed a coordinated national rollout of testing.

But Kalra said Fremont officials made sure BioGenex held up its part of the supply chain."We are not slowing it down," he said.